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High Flow Nasal Cannula (HFNC) Initiation Flow Rate Study

Primary Purpose

Bronchiolitis

Status
Suspended
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Initial Flow Rate
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiolitis focused on measuring Bronchiolitis, HFNC, High Flow Nasal Cannula, Infants

Eligibility Criteria

7 Days - 12 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients less than 12 months of age
  • Clinical signs of moderate to severe bronchiolitis defined by American Academy of Pediatrics
  • Requires ICU level of care by clinicians' discretion
  • Requiring HFNC support

Exclusion Criteria:

  • Infants who required immediate need for respiratory support such as non-invasive positive pressure ventilation (NIPPV) or invasive ventilation
  • Congenital heart disease,
  • Immunocompromised state
  • Upper airway obstruction
  • Chronic lung disease
  • Bronchopulmonary dysplasia,
  • Home oxygen therapy requirement
  • Acute trauma patients
  • Baseline craniofacial malformations
  • Admitted to the neonatal or cardiac ICUs
  • Patients who are admitted to the floor

Sites / Locations

  • Children's Health - Children's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm 1, HFNC 1 L/kg/min

Arm 2, HFNC 1.5 L/kg/min

Arm 3, HFNC 2 L/kg/min

Arm Description

The infant that is randomized to the HFNC therapy arm 1 will be placed on high flow at 1 L/kg/min (up to a maximum of 20 L/min) on fraction of inspired oxygen (FiO2) of 21 %. They will remain on FiO2 of 21% for a minimum of 10 minutes while monitoring SpO2. If oxygen saturation (SpO2) is <90%, FiO2 will be slowly increased to maintain SpO2 ≥ 90 %.

The infant that is randomized to the HFNC therapy arm 2 will be placed on high flow at 1.5 L/kg/min (up to a maximum of 20 L/min) on fraction of inspired oxygen (FiO2) of 21 %. They will remain on FiO2 of 21% for a minimum of 10 minutes while monitoring SpO2. If SpO2 is <90%, FiO2 will be slowly increased to maintain SpO2 ≥ 90 %.

The infant that is randomized to the HFNC therapy arm 3 will be placed on high flow at 2 L/kg/min (up to a maximum of 20 L/min) on fraction of inspired oxygen (FiO2) of 21 %. They will remain on FiO2 of 21% for a minimum of 10 minutes while monitoring SpO2. If SpO2 is <90%, FiO2 will be slowly increased to maintain SpO2 ≥ 90 %.

Outcomes

Primary Outcome Measures

Treatment response to HFNC Therapy
Determined by Respiratory Distress Assessment Instrument (RDAI) score and Respiratory Assessment Change Score (RACS) and heart rate improvement by 10%. The RDAI score assigns a score base on respiratory rate (RR), extent of wheezing, and retractions. It ranges from 0-17, higher score indicates severe bronchiolitis. To determine RACS: A decrease in RR by 10% is +1 change unit. Increase of 10% was defined as -1 change unit. Subsequent RDAI score is subtracted from the previous RDAI score to obtain the change. (ie. if initial score is 7 and the reassessment score is 3, the patient has a score of +4) Positive score is indicative of improvement, and negative score demonstrates deterioration. The overall RACS is calculated as the sum of change scores. Improvement is defined as RACS ≥ 4 positive units. No improvement was defined as RACS < 4 positive units.

Secondary Outcome Measures

Treatment failure to HFNC Therapy
Need for an increase in initial flow setting as determined by treating physician during the first 24 hours of hospitalization Escalation to other forms of non-invasive ventilatory support (i.e. NCPAP or BIPAP) Need for invasive ventilation
Length of oxygen support
Number of hours on HFNC Number of hours on simple nasal cannula
Length of stay
Length of stay in the pediatric ICU Length of stay in the hospital

Full Information

First Posted
August 15, 2020
Last Updated
June 30, 2023
Sponsor
University of Texas Southwestern Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04517344
Brief Title
High Flow Nasal Cannula (HFNC) Initiation Flow Rate Study
Official Title
High Flow Nasal Cannula (HFNC) Initiation Flow Rate Study - A Single Center, Randomized Controlled, Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Suspended
Why Stopped
protocol changes in the hospital
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators propose an open label, non-blinded, single center randomized controlled feasibility study to find the optimal initial HFNC flow rate in children less than 12 months old with clinically diagnosed moderate to severe bronchiolitis. This feasibility study is projected over December 2020 to April 2023. The study is consisted of 3 arms, comparing HFNC therapy at 1 L/kg/min, 1.5 L/kg/min, and 2 L/kg/min (20 L/min max). Moderate to severe bronchiolitis is defined clinician's assessment for the need for ICU level of care. The primary outcome is treatment response to HFNC therapy defined by RDAI/Respiratory Assessment Change Score (RACS) ≥ 4 at 4 hours of therapy. Secondary outcome measures comprise of treatment failure requiring an escalation of care during the first 24 hours of HFNC therapy, duration of HFNC and simple nasal cannula therapy, duration of simple nasal cannula therapy, hospital and PICU length of stay (LOS), time to treatment failure, and adverse events.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiolitis
Keywords
Bronchiolitis, HFNC, High Flow Nasal Cannula, Infants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1, HFNC 1 L/kg/min
Arm Type
Experimental
Arm Description
The infant that is randomized to the HFNC therapy arm 1 will be placed on high flow at 1 L/kg/min (up to a maximum of 20 L/min) on fraction of inspired oxygen (FiO2) of 21 %. They will remain on FiO2 of 21% for a minimum of 10 minutes while monitoring SpO2. If oxygen saturation (SpO2) is <90%, FiO2 will be slowly increased to maintain SpO2 ≥ 90 %.
Arm Title
Arm 2, HFNC 1.5 L/kg/min
Arm Type
Experimental
Arm Description
The infant that is randomized to the HFNC therapy arm 2 will be placed on high flow at 1.5 L/kg/min (up to a maximum of 20 L/min) on fraction of inspired oxygen (FiO2) of 21 %. They will remain on FiO2 of 21% for a minimum of 10 minutes while monitoring SpO2. If SpO2 is <90%, FiO2 will be slowly increased to maintain SpO2 ≥ 90 %.
Arm Title
Arm 3, HFNC 2 L/kg/min
Arm Type
Experimental
Arm Description
The infant that is randomized to the HFNC therapy arm 3 will be placed on high flow at 2 L/kg/min (up to a maximum of 20 L/min) on fraction of inspired oxygen (FiO2) of 21 %. They will remain on FiO2 of 21% for a minimum of 10 minutes while monitoring SpO2. If SpO2 is <90%, FiO2 will be slowly increased to maintain SpO2 ≥ 90 %.
Intervention Type
Other
Intervention Name(s)
Initial Flow Rate
Intervention Description
Patients placed on High Flow Nasal Cannula by treating physician will be randomized to initial flow rates of 1 L/kg/min, 1.5 L/kg/min, or 2 L/kg/min
Primary Outcome Measure Information:
Title
Treatment response to HFNC Therapy
Description
Determined by Respiratory Distress Assessment Instrument (RDAI) score and Respiratory Assessment Change Score (RACS) and heart rate improvement by 10%. The RDAI score assigns a score base on respiratory rate (RR), extent of wheezing, and retractions. It ranges from 0-17, higher score indicates severe bronchiolitis. To determine RACS: A decrease in RR by 10% is +1 change unit. Increase of 10% was defined as -1 change unit. Subsequent RDAI score is subtracted from the previous RDAI score to obtain the change. (ie. if initial score is 7 and the reassessment score is 3, the patient has a score of +4) Positive score is indicative of improvement, and negative score demonstrates deterioration. The overall RACS is calculated as the sum of change scores. Improvement is defined as RACS ≥ 4 positive units. No improvement was defined as RACS < 4 positive units.
Time Frame
4 hours of therapy
Secondary Outcome Measure Information:
Title
Treatment failure to HFNC Therapy
Description
Need for an increase in initial flow setting as determined by treating physician during the first 24 hours of hospitalization Escalation to other forms of non-invasive ventilatory support (i.e. NCPAP or BIPAP) Need for invasive ventilation
Time Frame
24 hours from time of study
Title
Length of oxygen support
Description
Number of hours on HFNC Number of hours on simple nasal cannula
Time Frame
24 hours from time of study
Title
Length of stay
Description
Length of stay in the pediatric ICU Length of stay in the hospital
Time Frame
24 hours from time of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients less than 12 months of age Clinical signs of moderate to severe bronchiolitis defined by American Academy of Pediatrics Requires ICU level of care by clinicians' discretion Requiring HFNC support Exclusion Criteria: Infants who required immediate need for respiratory support such as non-invasive positive pressure ventilation (NIPPV) or invasive ventilation Congenital heart disease, Immunocompromised state Upper airway obstruction Chronic lung disease Bronchopulmonary dysplasia, Home oxygen therapy requirement Acute trauma patients Baseline craniofacial malformations Admitted to the neonatal or cardiac ICUs Patients who are admitted to the floor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Cheng, MD
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Health - Children's Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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High Flow Nasal Cannula (HFNC) Initiation Flow Rate Study

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